Statistician - CMC & Biopharmaceutical ManufacturingSOKOL GxP Services • New Brunswick, NJ, US

Statistician - CMC & Biopharmaceutical Manufacturing

SOKOL GxP Services • New Brunswick, NJ, US

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Statistician is responsible for providing statistical analysis, direction, and training to service clients in Global Product Development & Supply (GPS) to ensure robust processes and methods, thereby delivering product quality and compliance.

Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses. Support and guidance in relation to study design and data analysis are provided worldwide to the client’s facilities.

Requirements

EDUCATION :

Required M.S. (with 2+ years of experience) or PhD (with no additional experience) in Statistics, Biostatistics, Applied Mathematics, or other related fields.

QUALIFICATIONS :

3+ years of experience in applying statistical methodologies such as Linear regression, Analysis of variance (ANOVA), Design of Experiments (DoE), Mixed models, and Multivariate Analysis to real datasets.

3+ years of experience in one or more statistical software (e.g., JMP, SAS, R, or Python).

1+ years of data analysis experience in the Biopharma space.

Strong communication skills and the ability to explain statistical techniques to non-statisticians.

Mastery of statistical methods such as Design of Experiments (DoE), Analysis of Variance (ANOVA), Mixed models, and Multivariate Analysis.

Advanced skills using one or more statistical software (e.g., JMP, SAS, R, or Python).

Ability to analyze and interpret scenarios, and through effective study design and statistical analysis, provide answers and appropriate courses of action.

Capable of managing multiple projects in a dynamic environment.

Strong communication skills and the ability to explain statistical techniques to non-statisticians.

Preferred Requirements (bonus points if you have) :

Biopharmaceutical development and manufacturing experience, with a strong preference for CMC statistics background.

Familiarity with FDA, EMA, and other global regulatory compliance guidelines (e.g., ICH guidelines) related to drug manufacturing, packaging, and distribution.

Knowledge of Statistical process control, Variance component analysis, and Bayesian methodology.

Benefits

Competitive hourly rate : $47.29 – $60 / hr (W-2 only, no C2C)

Job Type : Hybrid (50% on-site minimum)

Working Hours : Monday - Friday, business hours

Project Duration : 12-month contract with possible extension

Benefits : health insurance, 401(k) program, holiday pay, UTO, employee referral bonus program

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Statistician • New Brunswick, NJ, US